---
title: Refinement and Clinical Evaluation of the H-Man for Arm Rehabilitation After Stroke
nct_id: NCT02188628
overall_status: COMPLETED
phase: NA
sponsor: Tan Tock Seng Hospital
study_type: INTERVENTIONAL
primary_condition: Stroke
countries: Singapore
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02188628.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02188628"
ct_last_update_post_date: 2019-09-12
last_seen_at: "2026-05-12T06:31:33.414Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Refinement and Clinical Evaluation of the H-Man for Arm Rehabilitation After Stroke

**Official Title:** Refinement and Clinical Evaluation of the H-Man: A Novel, Portable, Inexpensive Planar Robot for Arm Rehabilitation After Stroke

**NCT ID:** [NCT02188628](https://clinicaltrials.gov/study/NCT02188628)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 44
- **Lead Sponsor:** Tan Tock Seng Hospital
- **Collaborators:** National Medical Research Council (NMRC), Singapore
- **Conditions:** Stroke
- **Start Date:** 2014-07-01
- **Completion Date:** 2018-03-31
- **CT.gov Last Update:** 2019-09-12

## Brief Summary

Locally, stroke remains the 4th cause of death, causing 8.4% of deaths annually in Singapore, and a leading cause of neurological disability worldwide. Nearly 40% of the stroke survivors will require specialized rehabilitation. In recent years, robot-aided therapy has been proposed as a means of complementing traditional therapy to alleviate the burden on therapists and on the healthcare system. For shoulder/elbow rehabilitation, dozens of robots have been proposed in the literature but only half a dozen have been commercialized and typically none are seen in local clinics, due to exceedingly high costs. A novel, compact, inexpensive robotic interface, named 'H-Man', was recently designed and developed at NTU for experiments in motor control neuroscience. The H-man can generate computer-controlled force fields to assist or resist a subject's motion and is potentially an optimal trade-off between clinical efficacy and robotic complexity. A first prototype of the H-Man is available at NTU.The primary aim of this proposed project is to assess to what extent the investigators H-Man is suitable for rehabilitation purposes using a feasibility pilot clinical trial design involving stroke survivors. The investigators believe that H-Man can be used for neuro-rehabilitation of stroke patients with hemiparetic weakness, motor incoordination and motor ataxia of the upper limbs.In close cooperation between clinicians at the TTSH and NTU engineers, a portable version of the H-Man will be developed which will be tested in a 12 subject Pilot study, refined and then used in a 44 subject Randomized Controlled Trial (RCT) study. At the same time, the feasibility of H-Man integration for a pared down home use model will be assessed in 4 subjects.

The investigators primary hypothesis is that sub-acute/chronic patients will exhibit clinically significant decreases of impairment when training with the H-Man combined with standard arm therapy on robot-measured scales and standardized clinical scales, at the level of elbow/shoulder after 18 sessions of training on the H-Man.

## Detailed Description

As above

## Eligibility

- **Minimum age:** 21 Years
- **Maximum age:** 85 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* First ever clinical stroke (ischaemic or haemorrhagic) confirmed on brain imaging
* Duration post stroke: 3 months to 24 months
* Age 21 to 85 years
* Hemiplegic pattern of arm motor impairment with Shoulder abduction MRC motor power \>/= 3/5 and elbow flexion MRC motor power \>/= 3/5
* Affected upper limb Fugl Myer Motor Assessment (FMMA) scale 20-50
* And / or associated motor incoordination or motor ataxia

Exclusion Criteria:

* Non stroke related causes of arm motor impairment
* Medical conditions incompatible with research participation: uncontrolled medical illnesses (hypertension or diabetes, heart failure, asthma, depression, end stage renal failure, terminal malignancy), life expectancy \<6 months, unhealed fractures or severe arm pain (visual analogue scale VAS \> 5/10, pregnancy
* Inability to tolerate sitting for 90 minutes.
* Local factors which preclude robotic interfacing or may be worsened by intensive arm therapy: spasticity of Modified Ashworth Scale grades 3-4, skin wounds, shoulder pain VAS \>5/10, active fractures or arthritis or fixed flexion contractures of shoulder, elbow, wrist or fingers incompatible with interface with the H-man robot.
* Severe sensory impairment of affected limb
* Severe visual impairment, hemispatial neglect or homonymous hemianopia
* Cognitive impairments or uncontrolled behaviour. (Folstein mini mental state exam MMSE \<26/28)
```

## Arms

- **H-Man** (EXPERIMENTAL) — H-Man is a novel, portable, inexpensive end-effector upper limb robot.
- **Additional Conventional Therapy** (ACTIVE_COMPARATOR) — Repetitive goals based arm therapy

## Interventions

- **H-Man** (DEVICE) — H-man is a portable end-effector planar upper limb robot.
- **Additional Conventional Therapy** (OTHER) — Repetitive goals based arm therapy

## Primary Outcomes

- **Change from Baseline in Fugl Meyer Assessment of Motor Recovery** _(time frame: 0, 3, 6, 12 and 24 weeks after start of intervention)_ — As above

## Secondary Outcomes

- **Change from Baseline in Action Research Arm Test** _(time frame: 0, 3, 6, 12 and 24 weeks after start of intervention)_

## Locations (1)

- Tan Tock Seng Rehabilitation Centre, Singapore, Singapore

## Recent Field Changes (last 30 days)

- `armsInterventions.interventions` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.tan tock seng rehabilitation centre|singapore||singapore` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT02188628*  
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